Genetic Alterations From Physical Therapy in Low Back Pain and Disc Degeneration

NCT07439874 | Completed DMC

• 2 other identifiers: UT-133-01-2021Research Grant
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Scientific Rationale: This prospective randomized controlled trial examines the combined effect of physiotherapy and vitamin D supplementation on pain, disability, interleukin-6 (IL-6) expression, and vitamin D levels in individuals with chronic low back pain (CLBP). The study details the demographic and metabolic profiles of CLBP patients compared to healthy controls, addressing a previously underexplored aspect of chronic musculoskeletal pain therapy. A total of 100 patients with chronic low back pain and 100 healthy controls were enrolled. Sixty patients with chronic low back pain were randomly assigned to either receive physiotherapy alone (which included interferential therapy and exercise) or to undergo physiotherapy combined with vitamin D supplementation over six weeks. The outcomes measured included the Numeric Pain Rating Scale (NPRS), the Arabic Oswestry Disability Index (AODI), serum IL-6 expression, and serum vitamin D levels, assessed at baseline and after the intervention.

Conditions

Genetic Alteration; Low Back Pain; Physiotherapy

Keywords

Chronic low back pain; Physiotherapy; Vitamin D Supplementation; Interleukin-6

Outcome Measures

Primary Outcomes (2)

• Numerical pain rating scale

  Patients assess their pain on an 11-point scale from 0-10

  6 weeks

• Arabic Oswestry Disability Scale

  A self-assessment tool used to evaluate physical disability. It has been utilized specifically to measure disability related to back pain

  6 weeks

Secondary Outcomes (2)

• Inflammatory biomarkers-IL-6

  6 weeks

• Vitamin D Parameters

  6 weeks

Study Arms (2)

Physiotherapy Treatment

EXPERIMENTAL

60 CLBP patients were randomized (30 per arm). Group A received physiotherapy only

Device: Interferential therapy

Physiotherapy and Vitamin D Supplementation

EXPERIMENTAL

60 CLBP patients were randomized (30 per arm) Group B received physiotherapy and Vitamin D supplementation

Device: Interferential therapy

Interventions

Interferential therapy DEVICE

Applied to lumbar region; standard protocol \[specify frequency, intensity, duration per session\]

Physiotherapy Treatment

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: The study includes participants of both genders, aged 20 to 70 years.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study involves participants with LBP for more than 3 months.
• Both genders, aged 20 to 70 years
• Pain intensity of 4 or greater on the Numeric Pain Rating Scale
• Capable of understanding and following instructions.

You may not qualify if:

• Skeletal deformities
• Rheumatologic conditions
• Progressive motor weakness
• Incontinence
• A history of cancer Use of systemic medications and illnesses Fractures.

Sponsors & Collaborators

• University of Tabuk: lead

Study Sites (1)

University of Tabuk

Tabuk, Tabuk Region, 71491, Saudi Arabia

Location

Related Publications (2)

• Pakkir Mohamed SH, Al Amer HS, Nambi G. The effectiveness of Kinesio taping and conventional physical therapy in the management of chronic low back pain: a randomized clinical trial. Clin Rheumatol. 2023 Jan;42(1):233-244. doi: 10.1007/s10067-022-06352-3. Epub 2022 Sep 1.

  PMID: 36045306 RESULT

• Mohamed SHP, Alatawi SF. Effectiveness of Kinesio taping and conventional physical therapy in the management of knee osteoarthritis: a randomized clinical trial. Ir J Med Sci. 2023 Oct;192(5):2223-2233. doi: 10.1007/s11845-022-03247-9. Epub 2022 Dec 17.

  PMID: 36527538 RESULT

MeSH Terms

Conditions

Congenital Abnormalities; Low Back Pain

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Physiotherapy: one group received interferential therapy and exercises, and the other group received physiotherapy and vitamin D supplementation prescribed by the physician

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: August 15, 2024
• Primary Completion: March 25, 2025
• Study Completion: January 15, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)